Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05740449
Status:
WITHDRAWN
Last Update Posted:
2024-06-21
First Post:
2023-02-13
Brief Title:
HEM-iSMART-A Decitabine Venetoclax and Navitoclax in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
Sponsor:
Princess Maxima Center for Pediatric Oncology
Organization:
Princess Maxima Center for Pediatric Oncology
Study Overview
Official Title:
International Proof of Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory HEMatological Malignancies in Children Subprotocol A Decitabine Venetoclax and Navitoclax in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
Status:
WITHDRAWN
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company stopped development and production of one of the IMPs
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEM-iSMART A
Brief Summary:
HEM-iSMART is a master protocol which investigates multiple investigational medicinal products in children adolescents and young adults AYA with relapsedrefractory RR ALL and LBL Sub-protocol A is a phase III trial evaluating the safety and efficacy of Decitabine Venetoclax and Navitoclax in children and AYA with RR pediatric ALLLBL
Detailed Description:
HEM-iSMART is a master protocol with sub-protocols The overarching objective is that introducing targeted therapy using a biomarker driven approach for treatment stratification may improve the outcome of children with RR acute lymphoblastic leukemia ALL and lymphoblastic lymphoma LBL It is characterized by a shared framework that allows for the investigation of multiple IMPs and generate pivotal safety and efficacy evidence within the sub-protocols to establish and define the benefits and risks of new treatments for children with RR leukemia
Sub-protocol A within HEM-iSMART is a phase III multicenter international open-label clinical trial designed to evaluate the safety tolerability pharmacokinetics PK and efficacy of decitabine venetoclax and navitoclax in children adolescents and young with RR ALL and LBL The epigenetic approach may improve outcome for patients whose tumor lack molecular alterations
Sub-protocol A within HEM-iSMART is a phase III multicenter international open-label clinical trial designed to evaluate the safety tolerability pharmacokinetics PK and efficacy of decitabine venetoclax and navitoclax in children adolescents and young with RR ALL and LBL The epigenetic approach may improve outcome for patients whose tumor lack molecular alterations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None